REFERENCE FORMULA
Reference formula
Reference basis: 1000 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Calamine | 40 g | — |
| Zinc oxide | 30 g | — |
| Liquid paraffin | 200 g | — |
| Self-emulsifying glyceryl monostearate | 50 g | — |
| Cetomacrogol emulsifying wax BP | 50 g | — |
| Phenoxyethanol | 5 g | — |
| Freshly boiled and cooled purified water | q.s. ad 1000 g | — |
REFERENCE FORMULA SCALING
Proportional quantities of the same formula
Arithmetic aid. It does not change strength, dose, method or BUD and does not authorise compounding.
Theoretical calculation sheet
CGR-BP-001 · Aqueous Calamine Cream
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
Documentation
Preparation description
Cream: Aqueous Calamine Cream. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Specifications
Zn: 4.3-5.2% w/w [1]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
Calamine is practically insoluble in water.
ZnO: practically insoluble in water.
Phenoxyethanol: water solubility 25 g/L at 20 °C, pH 7. Its phase distribution in a cream cannot be inferred solely from total concentration.
Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water. [2], [3], [5], [7]
ZnO: practically insoluble in water.
Phenoxyethanol: water solubility 25 g/L at 20 °C, pH 7. Its phase distribution in a cream cannot be inferred solely from total concentration.
Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water. [2], [3], [5], [7]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
Phenoxyethanol raw material: SCCS reports a flash point of 126 °C and boiling point of 244.3 °C; these do not set the cream’s storage temperature. [5]
pH and compatibility
Other interactions
Phenoxyethanol reacts with strong oxidants. [6]
Ingredient-specific information
Calamine of the cited specification is basic zinc carbonate containing traces of iron(III) oxide. Sieving and trituration reduce aggregates. Levigate using only the component and sequence prescribed in this monograph’s method; do not add an unlisted polyol or extra liquid.
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Phenoxyethanol (CAS 122-99-6): colourless oily liquid; relative density 1.11 at 20 °C, log Pow 1.2; water solubility 25 g/L at 20 °C and pH 7.
Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP.
Phenoxyethanol in this formula: total 0.5% w/w. Concentration alone is not a preservative-effectiveness test. [1], [2], [3], [5], [7]
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Phenoxyethanol (CAS 122-99-6): colourless oily liquid; relative density 1.11 at 20 °C, log Pow 1.2; water solubility 25 g/L at 20 °C and pH 7.
Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP.
Phenoxyethanol in this formula: total 0.5% w/w. Concentration alone is not a preservative-effectiveness test. [1], [2], [3], [5], [7]
Staff protection
Phenoxyethanol: protective gloves, clothing and safety goggles; ventilation and prevention of mist generation.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [1], [4], [6], [8]
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [1], [4], [6], [8]
Risk assessment
Phenoxyethanol can be absorbed through skin and may irritate eyes, skin and respiratory tract.
Reference batch: 1000 g. First ingredient: Calamine, 40 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [6], [11], [13], [15]
Reference batch: 1000 g. First ingredient: Calamine, 40 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [6], [11], [13], [15]
Compounding conditions
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately. [1], [10], [12], [14]
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately. [1], [10], [12], [14]
Prerequisites
Cetomacrogol Emulsifying Wax: CGR-BP-010 [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
Compounding method
Melt wax and monostearate; add paraffin at about 60 °C. Dissolve phenoxyethanol in about 620 g water at 60 °C. Add oil phase to water phase and stir during cooling. Adjust the base to 930 g; incorporate the triturated powders (70 g). [1]
Observations
The assay limit refers to elemental Zn, not ZnO. [1]
Container and packaging
Selection for local assessment: tight semisolid tube or jar with a suitable lining. Check cleanliness, integrity, closure and material compatibility before filling. The specific monograph does not validate a particular commercial container. [1]
Quality control
Gravimetric assay: gently heat 4 g without spitting, remove base/carbon and ignite to constant mass. Each gram of residue represents 0.8034 g Zn. The residue is yellow when hot and white when cool.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [13]
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [13]
Storage
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [9]
Dispensing
Labelling
Aqueous Calamine Cream
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage:
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [15]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage:
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [15]
v9_controls
The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- British Pharmacopoeia 2016 — Aqueous Calamine Cream2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2ingredient action2026-09-10
- FN/2003/PA/008 CALAMINAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2ingredient action2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- European Commission SCCS — Opinion on Phenoxyethanol, SCCS/1575/166 October 2016pp. 6–7; physicochemical dataingredient facts2026-09-12
- ILO/WHO — International Chemical Safety Card 0538: 2-PhenoxyethanolAugust 2003Hazards, prevention, physical/chemical propertiesingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Liquid ParaffinJP XVIII, 2021; English textPrinted p. 1477; Description; Containers and storageraw-material monograph2026-09-12
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14
- EMA — Excipients in the labelling and package leaflet, Annex Revision 5Published 5 December 2025EN and EL worksheets: arachis oil, wool fat, cetostearyl/cetyl alcohol, chlorocresolCurrent primary excipient warnings; used as a scientific labelling reference, without claiming MAH obligations automatically apply to a compounded prescription2026-10-14